NCT03834766 is a Phase 3 clinical trial of AMPH ER Tab 5, 10, 15 and 20 mg in ADHD, sponsored by Tris Pharma, Inc..

Who is sponsoring NCT03834766?

NCT03834766 is sponsored by Tris Pharma, Inc..

What drugs are being tested in NCT03834766?

Interventions in NCT03834766: AMPH ER Tab 5, 10, 15 and 20 mg, AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg.

Is NCT03834766 still recruiting?

NCT03834766 is currently completed. Last updated 2 November 2023.

Are results published for NCT03834766?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-11-02 · How we verify

NCT03834766

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD

Completed Phase 3 Results posted Last updated 2 November 2023

What this trial tests

Phase 3 trial testing AMPH ER Tab 5, 10, 15 and 20 mg in ADHD in 130 participants. Completed in 19 October 2019.

Timeline

6 February 2019

Primary endpoint
19 October 2019

19 October 2019

Quick facts

Lead sponsor	Tris Pharma, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	130
Start date	6 February 2019
Primary completion	19 October 2019
Estimated completion	19 October 2019
Sites	3 locations across United States

Drugs / interventions tested

AMPH ER Tab 5, 10, 15 and 20 mg — full drug profile →
AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg — full drug profile →

Conditions studied

ADHD — all drugs for ADHD →

Sponsor

Tris Pharma, Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Lean Squares Mean (± Standard Error) of Math Test Score Over All Post-dose Time Points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 Hours Post-dose) Assessed During the Administration of Serial Math Tests at Visit 5 (Week 5) Primary · Pre-dose to 14 hour post-dose

The Total Math Score is the sum of the number of math problems attempted plus the number of math problems answered correctly and it provides an objective measure of performance that is time-sensitive, ADHD medication-sensitive, and well documented as a measure to evaluate ADHD medication effectiveness throughout the day. The Total Math Score ranges from 0-800 with higher scores indicating better performance.

Group	Value	95% CI
AMPH ER Tab	259.5	± 69.40
Matching Placebo	260.6	± 77.75

Change From Baseline in AISRS Total Score at Each Post-baseline Visit Secondary · Baseline, Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3), Visit 4 (week 4), Visit 5 (week 5)

AISRS scale was developed to better capture symptoms of ADHD in adult patients. The scale has 18 items scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points.

Visit 1

Group	Value	95% CI
AMPH ER Tab	-7.2	± 7.94
Matching Placebo	-5.3	± 5.95

Visit 2

Group	Value	95% CI
AMPH ER Tab	-11.2	± 9.45
Matching Placebo	-8.1	± 7.22

Visit 3

Group	Value	95% CI
AMPH ER Tab	-15	± 9.08
Matching Placebo	-8.8	± 8.38

Visit 4

Group	Value	95% CI
AMPH ER Tab	-15.4	± 10.36
Matching Placebo	-9.3	± 9.47

Visit 5

Group	Value	95% CI
AMPH ER Tab	-15.9	± 10.98
Matching Placebo	-9.5	± 10.05

Change From Baseline to Visit 5 on DSST Secondary · From baseline to week 5

The Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test presented on a single sheet of paper that requires a subject to match symbols to numbers according to a key located on the top of the page. The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function. The DSST is a 90 second test requiring participants to match symbols with numbers according to a code. Potential scores range from 0 to 100, and lower scores indicate worse performance.

Group	Value	95% CI
AMPH ER Tab	4.8	± 7.64
Matching Placebo	6.5	± 7.21

Change From Baseline on Total Math Test Score Over Each Post-dose Time Points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 Hours Post-dose) Assessed During the Administration of Serial Math Tests at Visit 5 (Week 5) Secondary · Visit 5 (week 5)

0.5 hours

Group	Value	95% CI
AMPH ER Tab	64.5	± 106.21
Matching Placebo	39.7	± 82.74

1 hours

Group	Value	95% CI
AMPH ER Tab	67.9	± 107.43
Matching Placebo	27.8	± 84.10

2 hours

Group	Value	95% CI
AMPH ER Tab	84.4	± 115.37
Matching Placebo	47.0	± 84.12

4 hours

Group	Value	95% CI
AMPH ER Tab	81.7	± 121.72
Matching Placebo	53.0	± 87.84

8 hours

Group	Value	95% CI
AMPH ER Tab	78.8	± 121.72
Matching Placebo	48.2	± 90.28

10 hours

Group	Value	95% CI
AMPH ER Tab	81.2	± 118.64
Matching Placebo	53.8	± 85.10

12 hours

Group	Value	95% CI
AMPH ER Tab	85.2	± 111.18
Matching Placebo	58.3	± 94.97

13 hours

Group	Value	95% CI
AMPH ER Tab	88.8	± 120.45
Matching Placebo	47.7	± 84.07

Change From Baseline in CGI-S Total Score at Each Post-baseline Visit Secondary · Baseline, Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3), Visit 4 (week 4), Visit 5 (week 5)

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

Visit 1

Group	Value	95% CI
AMPH ER Tab	-0.6	± 0.89
Matching Placebo	-0.3	± 0.52

Visit 2

Group	Value	95% CI
AMPH ER Tab	-1.0	± 1.02
Matching Placebo	-0.6	± 0.68

Visit 3

Group	Value	95% CI
AMPH ER Tab	-1.3	± 1.20
Matching Placebo	-0.6	± 0.79

Visit 4

Group	Value	95% CI
AMPH ER Tab	-1.4	± 1.17
Matching Placebo	-0.8	± 1.10

Visit 5

Group	Value	95% CI
AMPH ER Tab	-1.3	± 1.24
Matching Placebo	-0.7	± 0.97

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AMPH ER Tab

Serious: 0/62 (0%)

Deaths: 0/62

Matching Placebo

Serious: 0/65 (0%)

Deaths: 0/65

Other adverse events (11 terms — click to expand)

Reaction	System	AMPH ER Tab	Matching Placebo
Decreased Appetite	Metabolism and nutrition disorders	—	—
Insomnia	Psychiatric disorders	—	—
Dry Moutn	Gastrointestinal disorders	—	—
Irritability	Psychiatric disorders	—	—
Headache	Nervous system disorders	—	—
Initial insomnia	Psychiatric disorders	—	—
Anxiety	Psychiatric disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Dizzines	Nervous system disorders	—	—
Tachycardia	Cardiac disorders	—	—
Fatigue	General disorders	—	—

Data from ClinicalTrials.gov NCT03834766 adverse events section.

Sponsor's own description

To evaluate the efficacy of AMPH ER TAB compared to placebo in adult patients with ADHD aged 18 to 60 years.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder.
Cutler AJ, Childress AC, Pardo A, Duhoux S, et al · · 2022 · cited 4× · PMID 35857716 · DOI 10.4088/jcp.22m14438

Verify or expand the search:

Other recruiting trials for ADHD

Currently open trials in the same condition.

NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
NCT07262853 — Dual Executive Function Training Package · NA · recruiting
NCT07291453 — Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits · NA · recruiting
NCT07281092 — Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) · NA · recruiting
NCT07219810 — Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD · NA · recruiting

Other Tris Pharma, Inc. trials

Trials by the same sponsor.

NCT06545097 — A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty · Phase 3 · completed
NCT06423703 — A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy · Phase 3 · completed
NCT06453265 — A Study to Assess the Abuse Potential of Intranasal Cebranopadol · Phase 1 · completed
NCT05491785 — Cebranopadol Effects on Ventilatory Drive, Central Nervous System (CNS) and Pain. · Phase 1 · completed
NCT05256108 — Assessment of Abuse Potential of Cebranopadol in Humans · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03834766 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tris Pharma, Inc.
Last refreshed: 2 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03834766.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing